QC Analyst II

OrganaBio • San Diego, CA

17d • $33 - $37

About The Position

The Quality Control Analyst will be an integral part of the QC Lab startup and implementation at Excellos Labs, performing QC testing for the company. The role requires cGMP testing according to established procedures, contributions to assay and equipment validations, data analysis, and maintaining records, reports, and data. The Analyst will participate in departmental meetings and educational programs, support Excellos Labs’ safety, GMP, and Quality plans, and assist with continuous improvement of systems to support a growing company.

The position primarily works in a laboratory setting with biohazard precautions. The work may involve exposure to blood or bodily fluids capable of transmitting diseases and potentially hazardous chemicals. The Analyst may be called on to work or attend meetings outside routinely scheduled hours. The role requires computer use, operation of laboratory equipment, repetitive motions such as pipetting, prolonged standing, clear communication, lifting up to 40 pounds, and the ability to gown into an ISO7 cleanroom. The regular schedule is Monday through Friday, 8 a.m. to 6 p.m. The salary range is $33–$37 per hour.

Requirements

• Bachelor’s degree in a science-related field.
• Minimum of 5 years of related laboratory experience.
• Strong attention to detail and ability to follow written procedures.
• Laboratory experience with working knowledge of basic laboratory procedures.
• Previous experience with sterile technique and human biospecimens.
• Previous cGMP experience required.
• Keen attention to detail, organization, self-motivation, flexibility, independent work with changing priorities, and good time management.
• Ability to perform advanced troubleshooting of scientifically technical problems.
• Ability to adapt to new technologies.
• Interpersonal skills to establish and maintain professional relationships.
• Ability to collaborate as a team member and communicate effectively in an interdisciplinary environment.
• Ability to work under pressure and meet critical timelines.
• Ability to work, learn, adapt, and execute in a fast-paced commercial environment.
• Ability to work on a computer up to 4–8 hours per day.
• Ability to operate laboratory equipment and accommodate repetitive motion such as pipetting.
• Ability to stand for prolonged periods, communicate clearly, lift up to 40 pounds, and gown into an ISO7 cleanroom.

Nice To Haves

• Experience in cell therapy GMP areas, including QC testing laboratories, manufacturing, and process development; QC testing laboratory experience is preferred.
• Proficiency in flow cytometry, cell counting, sterility, and potency methods.

Responsibilities

• Execute cGMP testing for cell therapy products.
• Follow Good Documentation Practices and maintain comprehensive records for testing, equipment, and sample management.
• Assist with validation and implementation of novel testing methods.
• Collaborate with area managers to ensure accuracy and adherence to production schedules.
• Assist with sample submission to contract laboratories.
• Identify and assess operational risks, and communicate issues to senior management and cross-functional support teams.
• Analyze data and review and approve QC assays and contract laboratory testing documentation.
• Assist with generating Certificates of Analysis.
• Troubleshoot, investigate, and perform root cause analysis in a cGMP environment.
• Use aseptic processing techniques to analyze samples and manipulate and aliquot bioproducts in biosafety cabinets.
• Oversee routine maintenance of laboratory equipment and the environment.
• Maintain complete, accurate, legible, neat, organized, and current records and laboratory notebooks.
• Maintain supply inventory levels and order laboratory reagents and supplies as needed.
• Adhere to production schedules to support on-time production logistics and fulfillment of client requests.
• Compile data and prepare reports for internal use and external customer reporting.
• Support generation and revision of documentation, including SOPs, validation protocols, reports, deviations, and change controls.
• Work under minimal supervision and independently attend to details, investigate, review, and troubleshoot problems.
• Support internal and external technology transfer efforts by participating in project teams and external client meetings and completing deliverables on time.
• Perform peer review of manufacturing and testing records.
• Provide regular updates, data, and applicable documentation for project teams.
• Participate in departmental meetings and educational programs and support safety, GMP, and Quality plans.
• Assist with continuous improvement of systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level